NMES in Critically Ill Patients

Not Applicable

Completed

• Conditions: Critically Ill Patients With a Predicted Prolonged ICU Stay
• Interventions: Other: electrical stimulation

• Registration Number: NCT02133300
• Lead Sponsor: KU Leuven

Brief Summary

Critically ill patients with a predicted prolonged ICU stay will receive neuromuscular electrical stimulation (NMES) of one quadriceps muscle. Whether the dominant or non-dominant side will be stimulated is chosen randomly by using opaque sealed envelopes. The patients will receive electrical stimulation for 1h for 7 consecutive days. The stimulated and non-stimulated side will be compared for it's thickness (by using ultrasound imaging), muscle strength if the patients are awake and cooperative (using the medical research council scale and handheld dynamometry) and a muscle biopsy will be taken. As a primary outcome the investigators hypothesize that electrical stimulation will preserve muscle mass with respect to the non-stimulated quadriceps. As secondary outcomes the investigators hypothesize that electrical stimulation can reduce muscle strength loss and leads to a better protein balance and thicker muscle fibers in the stimulated quadriceps.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-08
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All adult ICU patients with a predicted prolonged ICU stay

Exclusion Criteria

• Preexisting neuromuscular disease, polyneuropathy or myopathy (e.g. Guillain-Barré, myasthenia gravis, Amyotrophic Lateral Sclerosis, paraplegia, multiple sclerosis, ...)
• Receiving neuromuscular blocking agents
• Musculoskeletal conditions of the pelvis and/or lower limb (e.g. fractures, skin disease )
• Focal neurological conditions of the pelvis and/or lower limb
• Skin disease (e.g. burns)
• Presence of a pace-maker or defibrillator
• Hemodynamic or Respiratory Instability, active cardiac ischemia
• High fever (>39°)
• Pregnancy
• Brain death
• Intracranial pressure >20 mmHg
• An anticipated fatal outcome
• Psychiatric disorders or severe agitation
• Re-admission to the ICU

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
electrical stimulation	electrical stimulation	Compex 3 professional NMES for 60' per day

Primary Outcome Measures

Name	Time	Method
Muscle thickness	post intervention period	Ultrasound measure in cm

Secondary Outcome Measures

Name	Time	Method
Muscle strength (MRC & HHD)	post intervention period	MRC: scale HHD: MicroFET, in kg Force
Protein balance	post intervention	biopsy using Bergström-Stille 5mm needles
Muscle fiber thickness	post intervention period	biopsy using Bergström-Stille 5mm needles

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium